Kornimate/medical-research-clean huggingface dataset:
pilot study of the treatment of erectile dysfunction (ed) with extracorporeal shockwave therapy (eswt)

Conditions: Erectile Dysfunction

Summary: the objective of the pilot study is to assess the feasibility of a full randomised, placebo-controlled clinical trial.the aim is to demonstrate that penile shockwave application in patients with erectile dysfunction of vascular origin leads to a greater increase in potency than in the control group.


Eligibility criteria:
inclusion criteria: * erectile dysfunction for more than 6 months * informed consent * positive effect of phosphodiesterase type 5 inhibitor (pde5i) * iief-15 score less than 20 * no neurological disease * stable partnership for more than 3 months * age 18-75 exclusion criteria: * total prostatectomy * another reason for ed except for vascular disorder * clinically significant hematological disease * heart stroke, arrythmia during the last 6 months * cancer during the last 5 years * intake of antiandrogen * ed treatment with the last 7 days * iief score higher than, equal to 20 * previous shockwave treatment

Keywords: iief score ed
the use of local hemostatic in patients with large incisional hernias

Conditions: Hernia, Ventral

Summary: design of a simple blind randomized controlled trial study. large incisional hernia repair with use of local hemostatic hemoblock

design of a simple blind randomized controlled trial study. the total number of subjects was 66. in the main group (a) - 33, in the other group (b) - 33. operation - sublay retromuscular using prolene mesh implant. in group a hemoblock 15 ml in the retromuscular and 15 ml in the subcutaneous spaces were used. wounds were drained by vacuum-suction drainage. postoperative monitoring of early ultrasound examinations on the 3rd, 7th, 10th, 12th, 15th, 18th, 21st, 25th, 28th, 30th days after drainage removal. in group b were used a standard intervention (sublay retromuscular).

Eligibility criteria:
inclusion criteria: 1. asa i, ii, iii 2. the absence of oncological pathology 3. consent to participate in the study 4. large incisional hernia (hernial defect ≥10 cm in diameter and/or area of hernial defect ≥100 cm2) according to the classification of ehs, 2009 (w3); age 25-75 years exclusion criteria: 1. age older than 75 years 2. decompensated concomitant pathology, asa≥iv 3. patient refusal to participate in the study

Keywords: hernia
the efficacy of a standardized acupuncture regimen and amitriptyline compared with placebo as a treatment for pain caused by peripheral neuropathy in hiv-infected patients

Conditions: HIV Infections; Peripheral Nervous System Disease

Summary: to evaluate the separate and combined efficacy of a standardized acupuncture regimen and amitriptyline on the relief of pain due to peripheral neuropathy and on the quality of life of hiv-infected patients. both amitriptyline, an antidepressant, and acupuncture, a chinese medical approach that uses needles to relieve pain, have been used successfully to reduce pain in some people. it is not known how effectively these approaches relieve or reduce pain in patients with peripheral neuropathy secondary to hiv infection.

both amitriptyline, an antidepressant, and acupuncture, a chinese medical approach that uses needles to relieve pain, have been used successfully to reduce pain in some people. it is not known how effectively these approaches relieve or reduce pain in patients with peripheral neuropathy secondary to hiv infection. patients are randomized to receive either standardized point acupuncture or alternate point acupuncture treatment twice weekly for the first 6 weeks, then once weekly for the next 8 weeks, plus either oral amitriptyline or placebo daily for the entire 14 weeks. acupuncture points are located on the lower leg. patients are evaluated at weeks 6 and 14 and are asked to keep a daily pain diary.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * antiretroviral therapy. * nonsystemic treatment of kaposi's sarcoma. * maintenance with an existing regimen of analgesic medication or herbal treatment. concurrent treatment: required: * acupuncture. patients must have: * hiv infection. * lower extremity peripheral neuropathy secondary to hiv infection. * pain for at least 2 weeks prior to study entry. * life expectancy of at least 6 months. note: * co-enrollment in other experimental protocols is permitted as long as dual participation is allowed in those protocols. prior medication: allowed: * antiretroviral therapy. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * known allergy to amitriptyline (not applicable for patients at sites using an acupuncture only study design). * ekg indicating malignant arrhythmia or cardiac conduction disturbances (not applicable for patients at sites using an acupuncture only study design). * prison incarceration. concurrent medication: excluded: * active treatment for an acute opportunistic infection or malignancy (nonsystemic treatment of kaposi's sarcoma is permitted). * other tricyclic antidepressants. * mao inhibitors. patients with the following prior conditions are excluded (not applicable for patients at sites using an acupuncture only study design): * history of cardiac disease. * history of seizure disorder. prior medication: excluded within 2 weeks prior to study entry: * mao inhibitors. * tricyclic antidepressants.

Keywords: acquired immunodeficiency syndrome aids-related complex peripheral nervous system diseases amitriptyline pain acupuncture therapy
autologous hbv-tcr t cell therapy (liocyx-m) for the treatment of hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: this is a single center and open-label study to determine the safety and efficacy of mrna hbv-tcr redirected t-cells in hbv-related hcc who are not amenable to/failed conventional treatment.


Eligibility criteria:
inclusion criteria: * hcc diagnosis confirmed by histology/ cytology or clinically * hcc that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies * has failed at least one line of systemic therapy for hcc * ecog performance status ≤1 * serum hbsag positivity * child-pugh a (5 - 7 points) * life expectancy of at least 1 year * hla profile: hla-a\*02:01 or hla-a\*24:02 exclusion criteria: * brain metastasis * second primary malignancy that is clinically detectable at the time of consideration for study enrolment, except for in situ carcinoma of the cervix, non-melanoma skin carcinoma localized prostate cancer, ductal carcinoma in situ, or stage i uterine cancer and superficial bladder tumors * concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, tki therapy, and immunotherapy. * use of any investigational product (ip) or investigational medical device within 28 days of study drug administration * serum hbv dna levels ≥ 200 iu/ml at screening * serum hbsag levels ≥ 10,000 iu/ml at screening * women who are pregnant or breast-feeding
characterization and natural history of williams syndrome and other chromosome 7q11.23 variants

Conditions: Williams Beuren Syndrome; Williams Syndrome; Williams Beuren Region Duplication; Dup7

Summary: the goal of this observational natural history study is to better characterize development, transition to adulthood, health and behavior of individuals diagnosed with williams syndrome (ws) or carrying other variants of 7q11.23 chromosome and to build a dna and tissue biobank with samples donated by affected individuals. the study has multiple arms focused on different aspects of ws. participants with genetic diagnosis of ws or other variants of 7q11.23 and their family members are eligible to participate. study participants may participate in one or multiple arms of the study: 1. natural history genotype-phenotype study to test the hypothesis that health, behavior, and developmental variability observed in ws is determined by genetic factors and to characterize those genetic changes. participants of all ages are eligible to participate. either a blood or saliva sample is required for participation. 2. biobank: the research team is building a biobank enabling the development of new laboratory tools and models to study ws and test new treatment approaches. a blood sample is required for participation. participants of all ages are eligible to participate. 3. development arm of the study aims to delineate the development of language, cognition, personality, literacy and mathematics skills, and adaptive behavior from very early childhood through adulthood in individuals who have ws or dup7. the purpose of this study also includes determining the predictors of specific aspects of development (e.g., word reading ability, language ability, spatial ability) for individuals with ws or dup7. affected individuals of all ages are eligible to participate. 4. transition to adulthood study aims to understand how young adults with ws make a successful transition out of high school into adulthood and to help them in this journey by providing a comprehensive psychosocial transition coupled with a medical transition plan. individuals ages 14-25 years old are eligible to participate. study requires three in person visits.


Eligibility criteria:
inclusion criteria: * clinical and/or molecular diagnosis of williams syndrome (ws) * biological parents or siblings of individuals diagnosed with ws * molecular diagnosis of 7q11.23 duplication syndrome (dup7) * molecular diagnosis of another abnormality in the 7q11.23 region exclusion criteria: - no diagnosis of abnormalities in the 7q11.23 region, while not being a biological relative of affected individuals

Keywords: williams syndrome dup7 svas 7q11.23 autism
neoadjuvant chemotherapy plus chemoradiation in patients with potentially resectable gastric carcinoma

Conditions: Gastric Cancer

Summary: to investigate the feasibility, safety and tolerability of preoperative chemoradiation in patients with localized gastric cancer. primary endpoint: r0 resection rate. secondary endpoint: resection rate, pathological complete regression (pcr), effectiveness and safety of regime, disease free survival(dfs) and overall survival(os).

the prognosis of gastric cancer is poor partially due to low r0 resection rate. neoadjuvant chemoradiotherapy was reported to be effective in this setting by several phase ii studies. the investigators aim to evaluate the efficacy and toxicity of neoadjuvant chemoradiotherapy in a prospective phase ii study.

Eligibility criteria:
inclusion criteria: 1.18 ≤ age ≤ 70, male or female; 2.minimum life expectancy of 6 months; 3.patients with localized, histologically confirmed gastric or gastroesophageal adenocarcinoma; 4.patients must have a performance status of \ 1,500/µl, and platelet count of \> 100,000/µl), adequate liver function (bilirubin \<= 1.5 mg/dl), and adequate renal function (creatinine \<= 1.5 mg/dl). 11)patients without cardiac disease , severe uncontrolled diabetes, hypertension, cerebrovascular disease, or infection. exclusion criteria: 1. pregnant women are excluded from study entry due to the potential teratogenic effects of the study treatment; 2. female patients who planed to have a baby; 3. prior radiation therapy to the stomach, liver or kidney; 4. dysfunction of important organs such as liver, kidney or heart; 5.abnormalities of mental status; 6.active coronary artery disease; 7.cardiac arrhythmia, and need to receive medication therapy; 8.severe uncontrolled hypertension; 9.active clinical serious infection; 10.the known human immunodeficiency virus (hiv) infection history; 11.the known central nervous system diseases, including brain metastatic tumors; 12.patients have had clinical clear gastrointestinal bleeding in 6 months; 13.drug abuse; 14.swallowing difficulties for drugs; 15.poor compliance; 16.presence of concurrent or previous malignancies (except for cervical carcinoma in situ or basal cell carcinoma of the skin); 17.presence of peritoneal metastasis, distant organs or lymph nodes metastasis; 18.presence history of major surgery in the past three months; 19.poor tolerability; 20.prior history of medication; 21.allergy for chemotherapeutic drugs.
observational study of the safety and efficacy of norditropin® in adult patients with growth hormone deficiency

Conditions: Growth Hormone Disorder; Adult Growth Hormone Deficiency

Summary: this study is conducted in japan. the aim of this observational study is to collect information about the safety and efficacy of norditropin® long-term treatment of growth hormone deficiency in adults.


Eligibility criteria:
inclusion criteria: * severe adult growth hormone deficiency exclusion criteria: * known or suspected allergy to study product(s) or related products * previous participation in the study * diabetes mellitus * presence of malignant tumor(s) * pregnant or likely to get pregnant
development and validation of the modified version of vascuqol scale in patients with lower extremity peripheral arterial disease.

Conditions: Peripheral Arterial Disease

Summary: the purpose of this study is to assess the utility of the modified version of vascuqol scale as an effective biopsychosocial assessment tool for patients suffering from lower extremity peripheral arterial disease.

in the prior study, the original 25-item vascuqol scale demonstrates the limitation of dimensional mixing. as a result, we suggest improving the original scale by integrating the five dimensions and simplifying the objects. 480 patients will be recruited to complete the chinese version of vascuqol scale and the modified version. reliability, validity, responsiveness, and diagnostic accuracy for clti will be used to evaluate whether the modified scale could serve as an effective biopsychosocial assessment tool for patients suffering from lower extremity peripheral arterial disease. study procedures : after signing the informed consent form, eligible patients and/or their legal guardians will complete the questionnaires. outcome measures: patient-reported outcomes via specific questionnaires participant numbers: 480 patients will be recruited data management: data will be collected directly from the patients. all paper patient records will be kept in locked filing cabinet. electronic files will be saved on password protected folder oversight : i) data will be collected in a electric database; ii) all documents containing the identity of the participating subjects (non-objection, list of correspondence, etc.) will be kept away from personal data; iii) if it is a computerized document, it will be kept on the center's information server with access control by password.

Eligibility criteria:
inclusion criteria: 1. male or female aged 18-90 2. the patient is diagnosed with lower extremity peripheral arterial disease 3. the patient is willing to comply with specified follow-up evaluations at the specified times 4. the patient understands the nature of the procedure and provides written informed consent before enrolment in the study 5. before enrolment, the guidewire has crossed the target lesion 6. no restrictions on rutherford grading, tasc grading, glass grading exclusion criteria: 1. pregnant women or female patients with potential childbearing 2. the patient is currently participating in another investigational drug or device study that has not reached the primary endpoint. 3. patients unwilling or refusing to sign informed consent 4. patients with other diseases that may seriously affect the quality of life, such as tumors, severe liver disease, cardiac insufficiency, etc., or those with a life expectancy of less than 2 years
to evaluate the efficacy and safety in subjects with functional dyspepsia

Conditions: Functional Dyspepsia

Summary: to evaluate the efficacy and safety of z-338 in subjects with functional dyspepsia


Eligibility criteria:
inclusion criteria: * subjects presenting diagnosis of fd as defined by the rome ii * subjects presenting postprandial fullness and/or early satiety should be the most bothersome symptom exclusion criteria: -
cross-sectional survey on the use of tobacco products - germany

Conditions: Tobacco Use

Summary: the main purpose of the research study is to estimate the prevalence of tobacco product use and describe the tobacco use patterns in adults in germany.

the aim of the survey is to describe the current and past patterns of use of tobacco products in the general adult population of germany and in adult iqos users registered in the iqos user database of philip morris gmbh (germany iqos user database), and explore their association with key independent variables. more specifically, the objectives are: 1. estimate the prevalence of current tobacco use status in the study population. 2. describe the past tobacco use status (cigarette, iqos and other innovative products, including e-cigarettes) in the study population (i.e. never-use, initiation, product use transition, cessation, re-initiation, and relapse). 3. explore the association between self-reported health status and use of tobacco products in the study population. 4. explore the association between patterns of use (including misuse) with motivation to use, perceived quality attributes of iqos (e.g. risk and self-reported changes since switching to the product, in a number of relevant domains where iqos may have potential benefits), and consumer's satisfaction in the population of iqos users in germany registered in the germany iqos user database.

Eligibility criteria:
inclusion criteria (all participants, including iqos users): * legally permitted to buy tobacco products in germany (≥18 years of age). * currently residing in germany. * able to read, write and understand german. * consent to participate in the survey inclusion criteria (iqos users only): * has used more than 100 heets tobacco sticks in his or her lifetime. * is currently using iqos. * has access to the internet. * is not currently employed by philip morris international or any of its affiliates exclusion criteria: * not meeting the inclusion criteria

Keywords: tobacco use iqos
myopia control with the multi-segment lens

Conditions: Myopia

Summary: the purpose of this study is to determine if the multiple-segment (ms) spectacle lens can slow myopia progression in hong kong schoolchildren. ms lens is also called defocus incorporated multiple segments (dims) spectacle lens

ms lens is a novel lens designed in attempt to slow myopia progression. it is a multifocal spectacle lens which corrects distance refractive error and at the same time produces myopic defocus images on the retina for all distances. the myopic defocus aims at slowing down myopia progression. the purpose of this study is to investigate if the ms lens can slow myopia progression in hong kong chinese schoolchildren. the subjects will be randomly assigned to either treatment group (wear ms lenses) or control group (wear ordinary single vision lenses). their cycloplegic refraction and axial length will be monitored every six months over 2 years. the changes in refractive errors and axial length in two groups will be compared.

Eligibility criteria:
inclusion criteria: * age at enrolment: 8-13 year * spherical equivalent refractions (ser): -1.00 to -5.00 dioptres (d) * astigmatism and anisometropia of 1.50 d or less * spectacle corrected monocular logmar visual acuity: 0 or better * parents' understanding and acceptance of random allocation of grouping exclusion criteria: * any ocular and systemic abnormalities might affect visual functions or refractive development * prior treatment of myopic control, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc.
how bone is made in children receiving dialysis

Conditions: Bone Mineralization Defect

Summary: the study outlined is designed to measure and to determine whether the combined use of vitamin d2 (ergocalciferoi) and 1-alpha-hydroxyvitamin d2 (doxercalciferol)) or doxercalciferol alone will correct the mineralization defect in pediatric patients with established secondary hyperparathyroidism (2°hpt) undergoing regular peritoneal dialysis. serum phosphorus levels will be controlled with a calcium¬-free-metal free phosphate binder; (obtained at baseline and after 8 months of treatment) sevelamer. indices of bone mineralization obtained at baseline and after 8 months of treatment will be measured by quantitative histomorphometry in iliac crest bone biopsies after double tetracycline labeling. immunohistochemistry will be done in specimens of bone biopsies from iliac crest to examine the expression for selected markers of bone turnover and mineralization such as fgf-23, dmp1, mepe and opg. serum pth levels will be measured with the 1st and 2nd generation immunometric assay (pth-imas) and fibroblast growth factor-23 (fgf-23) will be determined by one assay with specific detection antibodies that are against epitopes within the c-terminus of fgf-23 and another assay that uses antibodies against epitopes within the n- and c-terminal portions of the molecule respectively. the value of non-invasive assessment of bone mass by quantitative computed tomography (qct) and its relationship with vascular disease determined by ultrasound (us) of intimal carotid thickness (cimt) will be correlated with bone histomorphometry and the different biochemical determinations.


Eligibility criteria:
inclusion criteria: * medically stable patients * 6-21 years old * undergoing treatment with continuous cycling peritoneal dialysis * evidence of mineralization defect and secondary hyperparathyroidism exclusion criteria: * histopathological lesion of bone such as adynamic bone or osteomalacia * poor compliance * current treatment with prednisone or other immunosuppressives * treatment with human recombinant growth hormone * parathyroidectomy
safety and efficacy of ledipasvir/sofosbuvir (ldv/sof) fixed dose combination (fdc) for 12 or 24 weeks in kidney transplant recipients with chronic hcv infection

Conditions: Hepatitis C Virus Infection

Summary: this study will evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (ldv/sof) fixed-dose combination (fdc) for 12 or 24 weeks in adults with chronic genotype 1 or genotype 4 hepatitis c virus (hcv) infection who have had a kidney transplant.


Eligibility criteria:
key inclusion criteria: * genotype 1 or 4 chronic hcv infection * have received a kidney transplant more than 6 months before the baseline visit * cirrhosis determination * screening laboratory parameters within defined thresholds * use of two effective contraception methods if female of childbearing potential or sexually active male key exclusion criteria: * pregnant or nursing female or male with pregnant female partner * hepatocellular carcinoma (hcc) or other malignancy (with exception of certain -resolved skin cancers) * history of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol * planned or anticipated second kidney transplant note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: renal transplant